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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Applicant BIOSENSE WEBSTER, INC productcode LPB Decision Date To 08/05/2015
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NAVISTAR THERMOCOOL CATHETER FOR RADIOFREQUENCY AB... BIOSENSE WEBSTER, INC. P030031 S031 09/23/2011
CELSIUS THERMOCOOL/RMT//NAVISTAR/NAVISTAR RMT/EZ S... BIOSENSE WEBSTER, INC. P030031 S032 04/06/2011
NAVISTAR RMT THERMOCOOL CATHETER BIOSENSE WEBSTER, INC. P030031 S033 01/13/2012
CELSIUS THERMOCOOL/CELSIUS RMT THERMOCOOL/NAVISTAR... BIOSENSE WEBSTER, INC. P030031 S035 10/07/2011
NAVISTAR RMT THERMOCOOL MAGNETIC STEERING CATHETER... BIOSENSE WEBSTER, INC. P030031 S036 12/12/2011
NAVISTAR RMT THERMOCOOL MAGNETIC STEERING CATHETER... BIOSENSE WEBSTER, INC. P030031 S037 12/23/2011
THERMOCOOL SF BI-DIRECTIONAL AND UNI-DIRECTIONAL C... BIOSENSE WEBSTER, INC. P030031 S039 06/15/2012
EZ STEER THERMOCOOL NAV CATHETER, NAVI-STAR ELEC... BIOSENSE WEBSTER, INC. P030031 S040 03/30/2012
NAVISTAR® THERMOCOOL® DIAGNOSTIC/ABLATION CATHETER... BIOSENSE WEBSTER, INC. P030031 S041 03/07/2013
CELSIUS THERMOCOOL, CELSIUS RMT THERMOCOOL, NAVIST... BIOSENSE WEBSTER, INC. P030031 S042 04/12/2013
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